TSCA Import-Export Requirements

TSCA Requirements for Importing Chemicals

New CBP Electronic Filing

The U.S. Customs and Border Protection (CBP) published a final rule on [insert data] requiring the use of the Automated Commercial Environment (ACE) when filing TSCA import certification statements electronically. Read the Federal Register notice. Learn more.

TSCA Import Certification Requirements

Imports of chemical substances, mixtures or articles that contain a chemical substance or mixture must comply with the Toxic Substances Control Act (TSCA) in order to enter the U.S. Importers must certify that imported chemical substances either comply with TSCA (positive certification) or are not subject to TSCA (negative certification). Certain chemicals require no certification.

CBP may detain or refuse entry of shipments if certification is not made, or if the shipment is believed not to be in compliance with TSCA.

Who Must Certify

A certification must be signed and filed with CBP by the:

importer of a chemical substance imported in bulk or as part of a mixture, or

importer’s authorized agent.

The statement must be typed, preprinted on the invoice, or otherwise included in the entry documentation and must be filed with the director of the port of entry before release of the shipment, except if a "blanket" certification is on file. Certification is required for substances that are imported and are received by mail or commercial carrier, including those intended for research and development.

Certification Statements

An importer's statement must certify either that the chemical shipment is:

subject to TSCA and complies with all applicable rules and orders (positive certification)

or that the chemical shipment is not subject to TSCA (negative certification)

Positive Certification Statement:

The following is a positive certification statement.

"I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order under TSCA."

A positive certification means that the chemical substance complies with all applicable TSCA regulations, including:

Section 5 premanufacture notification rules

Section 5 significant new use rules

Section 5(e) orders

Section 5(f) rules and orders

Section 6 rules and orders

Section 7 judicial actions

Title IV rules and orders

Note that sections 4 and 8 rules do not pertain to section 13 import certification requirements. Although importers must satisfy all applicable requirements of sections 4 and 8 rules, compliance with those provisions is not related to individual chemical shipments and therefore does not affect import certification.

Negative Certification Statement:

The following is a negative certification statement.

"I certify that all chemicals in this shipment are not subject to TSCA."

A negative certification is required for:

Any pesticide

Any food, food additive, drug, cosmetic or device

Source material, special nuclear material, or by-product material

Firearms and ammunitions as defined in section 3 of TSCA

No certification is required for the following:

Chemicals that are a part of articles, unless required by a specific rule under TSCA

Tobacco or tobacco products

Blanket Certification

“Blanket certification” may be requested from the port director on an annual basis to cover several shipments of the same chemical over a one year period instead of filing separate certification statements for each chemical shipment.

Import of New Chemicals and New Uses of Chemicals

TSCA section 3(7) defines the term "manufacture" to include import. This means that the section 5(a)(1)(A) requirement to submit a pre-manufacture notice ("PMN") to EPA at least 90-days before commencing non-exempt commercial manufacture of a new chemical substance in the United States applies to the import of new chemicals, as does the section 5(a)(1)(B) significant new use notice ("SNUN") requirement. Thus, the intended import of chemical substances can trigger the following provisions:

When appropriate, EPA issues section 5 regulatory requirements on new chemicals or significant new uses of chemicals via a TSCA section 5(e) order or section 5(a)(2) significant new use rule (SNUR, 40 CFR Part 721 or 725 Subparts L and M).

TSCA section 5(e) orders may include use prohibitions, labeling and Material Safety Data Sheet (MSDS) requirements, restrictions on the amount of the chemical allowed to be manufactured or imported, as well as other restrictions. (The import/production limits often serve as triggers for toxicity or related testing requirements.) SNURs require notifying EPA at least 90 days before manufacture, import, or processing for uses/activities designated by EPA as a significant new use.

To comply with these requirements when applicable, chemical substances must: